Breast CancerNCT03543072
A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Postmenopausal Breast Cancer Patients
An observational study of Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Breast cancer is one of the most common malignant tumor in women. About 69.75% of breast cancer women patients in China are over 45 years old. It is a multicenter prospective observational study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bisphosphonates
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2018to 15 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women with breast cancer who plan for adjuvant or neoadjuvant chemotherapy
Who may be able to join
- Informed consent form has been signed.
- Breast cancer patients whose age is ≥ 18 years old and have been diagnosed by histological examination.
- Postmenopausal women who are defined by any of the following:
- Previous bilateral oophorectomy;
- Age ≥ 60 years old;
- Age <60 years old, menopause at least 12 months, and follicle stimulating hormone [FSH] and estradiol levels in the postmenopausal range.
- Plan for adjuvant or neoadjuvant chemotherapy.
Who cannot join
- Those who have already received adjuvant or neoadjuvant chemotherapy.
- Those who have chemotherapy contraindications.
- Those who have any mental condition that prevents the understanding of the contents of this study and can't provide the complete information required.
Trial locations and contacts
1 site in 1 country.
China1 site
Shusen Wang
Guanzhou, Guangdong
Shusen Wang, doctor, +86-13926168469, wangshs@sysucc.org.cn
About this study
Official title: A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Postmenopausal Women With Breast Cancer
Breast cancer is one of the most common malignant tumor in women. About 69.75% of breast cancer women patients in China are over 45 years old. It is a multicenter prospective observational study. We collect the basic information, medical history, chemotherapy-related adverse reactions, and the results of blood lipid and bone density test before, during and after adjuvant or neoadjuvant chemotherapy. The purpose of the study is to investigate the risk factors for hyperlipidemia, cardiovascular disease, and osteoporosis in postmenopausal breast cancer patients before and after chemotherapy, and to assess the risk of future arteriosclerotic cardiovascular disease and osteoporotic fractures. In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.
Read the detailed description
Breast cancer is one of the most common malignant tumor in women. About 69.75% of breast cancer women patients in China are over 45 years old. Chemotherapy is one of the important treatments for breast cancer, but it brings a series of adverse effects, especially increasing the risk of hyperlipidemia, cardiovascular disease and osteoporosis in postmenopausal women. It is a multicenter prospective observational study. The postmenopausal breast cancer women patients who are planning adjuvant or neoadjuvant chemotherapy are enrolled in the study after signing the informed consent form and passing the screening. We collect the basic information, medical history, chemotherapy-related adverse reactions, and the results of blood lipid and bone density test before, during and after chemotherapy. The purpose of the study is to investigate the risk factors for hyperlipidemia, cardiovascular disease, and osteoporosis in postmenopausal breast cancer patients before and after chemotherapy, and to assess the risk of future arteriosclerotic cardiovascular disease and osteoporotic fractures in this population.In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.
- Conditions
- Breast Cancer
- Being tested
- Bisphosphonates
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisphosphonatesDrug
a class of drugs that prevent the loss of bone density, used to treat osteoporosis and similar diseases
| Study group | Role | What they receive |
|---|---|---|
| exposure group | exposed to some factors Receives: Drug: Bisphosphonates | |
| control group | not exposed to some factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of osteoporosis
According to the result of bone mineral density
Measured: 5 years
Secondary outcomes (1)
The risk of osteoporotic fracture
Calculate the risk of osteoporotic fracture with the WHO Fracture Risk Assessment Tool (FRAX® ) (http://www.shef.ac.uk/FRAX/)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start15 Jun 2018 (estimated)
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang shusen, Sun Yat-sen University
- Investigators
- Shusen Wang, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543072
- Sponsor's protocol ID
- SCBCG-022
- Status last verified
- Jun 2018
- First submitted
- 21 May 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Postmenopausal Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT03543072
- Acronym / sponsor ID
- SCBCG-022
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (estimated)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is one of the most common malignant tumor in women. About 69.75% of breast cancer women patients in China are over 45 years old. It is a multicenter prospective observational study. We collect the basic information, medical history, chemotherapy-related adverse reactions, and the results of blood lipid and bone density test before, during and after adjuvant or neoadjuvant chemotherapy. The purpose of the study is to investigate the risk factors for hyperlipidemia, cardiovascular disease, and osteoporosis in postmenopausal breast cancer patients before and after chemotherapy, and to assess the risk of future arteriosclerotic cardiovascular disease and osteoporotic fractures. In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.
Detailed description
Breast cancer is one of the most common malignant tumor in women. About 69.75% of breast cancer women patients in China are over 45 years old. Chemotherapy is one of the important treatments for breast cancer, but it brings a series of adverse effects, especially increasing the risk of hyperlipidemia, cardiovascular disease and osteoporosis in postmenopausal women. It is a multicenter prospective observational study. The postmenopausal breast cancer women patients who are planning adjuvant or neoadjuvant chemotherapy are enrolled in the study after signing the informed consent form and passing the screening. We collect the basic information, medical history, chemotherapy-related adverse reactions, and the results of blood lipid and bone density test before, during and after chemotherapy. The purpose of the study is to investigate the risk factors for hyperlipidemia, cardiovascular disease, and osteoporosis in postmenopausal breast cancer patients before and after chemotherapy, and to assess the risk of future arteriosclerotic cardiovascular disease and osteoporotic fractures in this population.In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposure group | – | Drug: Bisphosphonatesexposed to some factors |
| control group | – | –not exposed to some factors |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with breast cancer who plan for adjuvant or neoadjuvant chemotherapy
Key inclusion criteria (7 listed)
- Informed consent form has been signed.
- Breast cancer patients whose age is ≥ 18 years old and have been diagnosed by histological examination.
- Postmenopausal women who are defined by any of the following:
- Plan for adjuvant or neoadjuvant chemotherapy.
Key exclusion criteria (3 listed)
- Those who have already received adjuvant or neoadjuvant chemotherapy.
- Those who have chemotherapy contraindications.
- Those who have any mental condition that prevents the understanding of the contents of this study and can't provide the complete information required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bisphosphonatesa class of drugs that prevent the loss of bone density, used to treat osteoporosis and similar diseases | Drug | exposure group |
Primary outcome
The rate of osteoporosis
Time frame: 5 years
According to the result of bone mineral density
1 secondary outcome
The risk of osteoporotic fracture
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shusen Wang principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shusen Wang (+86-13926168469, wangshs@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of osteoporosis (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.